Breast Cancer, Breast Neoplasms
Conditions
Keywords
Breast Cancer, Neoadjuvant therapy for breast cancer
Brief summary
Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.
Detailed description
Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded. Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website. All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.
Interventions
OTHERGenomic and/or molecular testing of blood or tissue
Genomic and/or molecular testing of blood or tissue
Sponsors
Targeted Medical Education
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy * Ages 18-90 * Written informed consent
Exclusion criteria
* Patients who have had excisional biopsy or axillary dissection * Patients with confirmed metastatic disease * Patients who have had recent chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response and/or endocrine sensitivity | Post surgical treatment--usually within 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Metastasis-free/relapse-free survival in molecular subgroups | 5 years |
Countries
United States
Outcome results
None listed